Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
研究概览
简要总结
The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied.
108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 6 months.
Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use.
Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of intranasal cocaine dependence, according to DSM-IV-TR criteria
- •age between 18 and 60 years
- •current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
- •demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
- •place of residence compatible with attendance at the centre.
- •for women, willingness to use effective contraceptive measures during the study.
排除标准
- •diagnosis of a severe medical disorder that could interfere with the study
- •presence of an organic pathology for which methylxanthines or biperidene, iodine or apomorphine administration is contraindicated
- •serum liver transaminase levels 3 times higher than normal values
- •pregnancy and breast-feeding
- •neuroleptic medication treatment in the past 6 weeks
- •current treatment, or anticipation that the patient may need to initiate treatment during the study with drugs that may interact with study medication.
- •current diagnosis of a major mental disorder.
- •awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
- •current participation in another research project.
研究组 & 干预措施
1
This study arm will receive caffeine+placebo
干预措施: Caffeine (Drug)
2
this study arm will receive Caffeine+Biperiden
干预措施: Caffeine (Drug)
2
this study arm will receive Caffeine+Biperiden
干预措施: Biperiden (Drug)
3
this study arm will receive placebo+placebo
干预措施: Placebo (Drug)
结局指标
主要结局
1) comfort with cocaine detox defined as cocaine abstinence symptoms, cocaine craving, depressive symptoms and anxiety symptoms 2) study retention and 3) cocaine use.
时间窗: 12-14 days for primary otcome num 1 and 23 weeks for num 2 and 3.
次要结局
未报告次要终点